FDA Medical devices recall ·
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount recall
- Recall number
- Z-1663-2025
- Date
- (initiated March 27, 2025)
- Company / brand
- Ihb Operations B.V.
Floresstraat 52, Zwolle, N/A, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 112 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Why was it recalled?
The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 10841736116071, All Serial Numbers
Distribution
US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, ID, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NM, NY, PA, TN, TX, UT, VA, WI, WV.
States: Alabama Arizona California Florida Iowa Idaho Illinois Louisiana Massachusetts Maryland Michigan Minnesota North Carolina New Hampshire New Jersey New Mexico New York Pennsylvania Tennessee Texas Utah Virginia Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1663-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.